CompletedNCT04523480Updated Aug 14, 2023Results posted

Testopel ® vs. Generic Testosterone Pellets.

A Phase 3 interventional study of Testopel 75mg Drug Implant and Testopel 100mg Drug Implant in Hypogonadism, sponsored by University of Miami. Completed at 1 site in United States. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by University of Miami · Phase 3, Interventional, and Treatment

From the registry’s dates

Registered 4 months after the study started (first participant enrolled Mar 2020, registered Aug 2020).

Phase: Phase 3
Study type: Interventional
Enrollment: 75
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: Male

Study summary

The purpose of this study is to evaluate changes in vascular parameters in subjects receiving Testopel 75mg (one time) versus subjects receiving Compounded Testosterone pellets 100mg (one time) versus subjects receiving Compounded Testosterone pellets 200mg (one time) to participant with clinical hypogonadism.

Read the detailed description

Hypogonadism, or low testosterone (Low T), is the deficiency in producing testosterone by the testes. Testosterone pellets is a long-acting formulation of Testosterone Replacement Therapy (TRT) that is delivered subcutaneously to men diagnosed with low T. Advantages to subcutaneous testosterone pellets include ease of delivery and decreased risk of the medication being transfer upon skin contact to woman or children. Long acting testosterone replacement Implantation of six to ≥10 testosterone pellets (450 to ≥750 mg) increased total testosterone into the therapeutic range at 1 month post-implantation and sustained therapeutic levels (>300) for 4-6 months.

Participants will be randomly assigned to 1 of 3 study groups. In one of the groups the treatment will include implantation of Testopel ® 750mg (10 pellets with 75mg pellet) one time, in the second group, treatment will include compounded subcutaneous testosterone 800mg (8 pellets with 100mg pellet) one time and in the third group, treatment will include compounded subcutaneous testosterone 800mg (4 pellets with 200mg pellet) one time.

The treatment takes approximately 30 minutes and will include: Clean and numb the insertion site with lidocaine at 1%, followed by small incision in the skin, implantation of pellets into subdermal fat layer and sealing the incision with Steri-strip. This is the current standard of care of Testopel insertion and same procedure will be followed with both compounded and commercial pellets.

Conditions studied

Hypogonadism

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Hypogonadism 345

Keywords

Low T
Low Testosterone

In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's enrollment of 75 is above the median of 56 across 260 interventional studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

Voluntarily sign and date the study consent form(s), which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.
Male between 18 and 75 years of age.
Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
Serum total testosterone \< 300 ng/dL on 2 measurements
Naïve to androgen replacement or has discontinued current treatment and completed a washout of 4 weeks following androgen treatment.
Judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion criteria

Exclusion Criteria:

History of significant sensitivity or allergy to androgens, or product excipients.
Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up, abnormal ECG.
Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score > 19 points.
Body mass index (BMI) ≥ 40 kg/m2.
Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
1. Baseline hemoglobin > 16 g/dL
2. Hematocrit \< 35% or > 50%
3. prostate-specific antigen (PSA) > 4 ng/mL
History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.
History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.
History of stroke or myocardial infarction within the past 5 years.
History of, or current or suspected, prostate or breast cancer.
History of diagnosed, severe, untreated, obstructive sleep apnea.
History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.
Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 12 weeks prior to the start of treatment.
Inadequate venous access for collection of serial blood samples required for pharmacokinetic profiles.
Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment.
Inability to understand and provide written informed consent for the study.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 75 participants (actual)

Study arms

Experimental
Testopel 75mg Group
Participants in this group will receive a one-time subcutaneous testosterone insertion of 10 x 75 mg pellets of Testopel for a total of 750 mg Testopel.
Drug: Testopel 75mg Drug Implant
Active comparator
Compounded testosterone pellets 100mg Group
Participants in this group will receive a one-time subcutaneous testosterone insertion of 8 x 100 mg compounded testosterone for a total of 800 mg compounded testosterone.
Drug: Testopel 100mg Drug Implant
Active comparator
Compounded Testosterone pellets 200mg Group
Participants in this group will receive a one-time subcutaneous testosterone insertion of 4 x 200 mg compounded testosterone for a total of 800 mg compounded testosterone.
Drug: Testopel 200mg Drug Implant

Interventions

DrugTestopel 75mg Drug Implant
75 mg Testosterone pellets administered subcutaneously.
DrugTestopel 100mg Drug Implant
100 mg Testosterone pellets administered subcutaneously.
DrugTestopel 200mg Drug Implant
200 mg Testosterone pellets administered subcutaneously.

What researchers measure

Primary outcomes

Change in Testosterone (T) Levels
Changes in serum Testosterone levels are assessed in ng/dL
Time frame: Baseline, 2 months, 4 months, and 6 months

Secondary outcomes

Change in Hematocrit (Hct) Levels.
Changes in serum Hct levels are assessed in %.
Time frame: Baseline, 2 months, 4 months, and 6 months
Change in PSA Levels
Change in serum Prostate Specific Antigen (PSA) levels are assessed in ng/mL.
Time frame: Baseline, 2 months, 4 months, and 6 months
Change in Estradiol Levels
Change in serum estradiol levels are assessed in pg/mL.
Time frame: Baseline, 2 months, 4 months, and 6 months

Results

Posted Aug 14, 2023

Participant flow

Participant flow — Overall Study
Milestone	Testopel 75mg Group	Compounded Testosterone Pellets 100mg Group
Started	33	42
Completed	3	7
Not completed	30	35
Withdrew: Lost to follow-up	30	35

Outcome measures

PrimaryChange in Testosterone (T) Levels

Changes in serum Testosterone levels are assessed in ng/dL

Time frame:: Baseline, 2 months, 4 months, and 6 months
Reported as:: Median · ng/dL

Change in Testosterone (T) Levels
ng/dL	Testopel 75mg Group	Compounded Testosterone Pellets 100mg Group	Compounded Testosterone Pellets 200mg Group
Baseline	219.5 (194 to 252)	202.3 (143.5 to 256)	—
Month 2	543 (460 to 716.5)	696.5 (591 to 822)	—
Month 4	290 (209 to 439)	277 (228 to 378)	—
Month 6	209 (155 to 267)	241 (158 to 287)	—

SecondaryChange in Hematocrit (Hct) Levels.

Changes in serum Hct levels are assessed in %.

Time frame:: Baseline, 2 months, 4 months, and 6 months
Reported as:: Median · hematocrit percentage

Change in Hematocrit (Hct) Levels.
hematocrit percentage	Testopel 75mg Group	Compounded Testosterone Pellets 100mg Group	Compounded Testosterone Pellets 200mg Group
Baseline	43.7 (42.3 to 46.7)	42.8 (39.3 to 45.6)	—
Month 2	46.1 (42.4 to 49.4)	46.7 (42.1 to 48.4)	—
Month 4	45.9 (42.8 to 48.7)	45.8 (44.4 to 46.8)	—
Month 6	46 (43.1 to 47.3)	43 (40.8 to 46.7)	—

SecondaryChange in PSA Levels

Change in serum Prostate Specific Antigen (PSA) levels are assessed in ng/mL.

Time frame:: Baseline, 2 months, 4 months, and 6 months
Reported as:: Median · ng/mL

Change in PSA Levels
ng/mL	Testopel 75mg Group	Compounded Testosterone Pellets 100mg Group	Compounded Testosterone Pellets 200mg Group
Baseline	0.9 (0.5 to 1.6)	0.4 (0.3 to 0.8)	—
Month 2	1.1 (0.6 to 1.85)	0.75 (0.5 to 1.2)	—
Month 4	1 (0.5 to 1.6)	0.65 (0.5 to 1.2)	—
Month 6	0.8 (0.6 to 1.7)	0.5 (0.3 to 0.6)	—

SecondaryChange in Estradiol Levels

Change in serum estradiol levels are assessed in pg/mL.

Time frame:: Baseline, 2 months, 4 months, and 6 months
Reported as:: Median · pg/mL

Change in Estradiol Levels
pg/mL	Testopel 75mg Group	Compounded Testosterone Pellets 100mg Group	Compounded Testosterone Pellets 200mg Group
Baseline	18.2 (8.5 to 25)	20.6 (8.5 to 24.3)	—
Month 2	29.1 (21.3 to 35.4)	42.7 (42.1 to 48.4)	—
Month 4	13.7 (8.1 to 24.6)	18.4 (6.9 to 29.6)	—
Month 6	14.3 (0.1 to 17.6)	18.8 (7 to 22.7)	—

Adverse events

Collected over Adverse events were evaluated after implantation, and at each follow up visit (months 2, 4, and 6).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Testopel 75mg Group	0/33 (0%)	0/33 (0%)	1/33 (3%)
Compounded Testosterone Pellets 100mg Group	0/42 (0%)	0/42 (0%)	0/42 (0%)
Compounded Testosterone Pellets 200mg Group	—	—	—

Most frequent other events

Most frequent other events
Event	Testopel 75mg Group	Compounded Testosterone Pellets 100mg Group	Compounded Testosterone Pellets 200mg Group
Pellet ExtrusionSurgical and medical procedures	1/33	0/42	—

Baseline characteristics

No subjects were enrolled to the 200mg group due to complications with the compounding pharmacies ability to produce the medication.

Age, Continuous
Age, Continuous(years)	Testopel 75mg Group	Compounded Testosterone Pellets 100mg Group	Compounded Testosterone Pellets 200mg Group	Total
Median	54.5 (35 to 74)	52.5 (22 to 69)	—	53.5 (22 to 74)

Sex: Female, Male
Sex: Female, Male(Participants)	Testopel 75mg Group	Compounded Testosterone Pellets 100mg Group	Compounded Testosterone Pellets 200mg Group	Total
Female	0	0	0	0
Male	33	42	0	75

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Testopel 75mg Group	Compounded Testosterone Pellets 100mg Group	Total
Hispanic or Latino	24	29	53
Not Hispanic or Latino	9	13	22
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Testopel 75mg Group	Compounded Testosterone Pellets 100mg Group	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	3	6	9
White	6	7	13
More than one race	0	0	0
Unknown or Not Reported	24	29	53

Study locations

1 site

University of Miami, Department of Urology
Miami, Florida 33136, United States

References and documents

Publications

Corona G, Rastrelli G, Maggi M. Diagnosis and treatment of late-onset hypogonadism: systematic review and meta-analysis of TRT outcomes. Best Pract Res Clin Endocrinol Metab. 2013 Aug;27(4):557-79. doi: 10.1016/j.beem.2013.05.002. Epub 2013 Jul 5. PubMed 24054931 ↗
Walker WH. Testosterone signaling and the regulation of spermatogenesis. Spermatogenesis. 2011 Apr;1(2):116-120. doi: 10.4161/spmg.1.2.16956. PubMed 22319659 ↗
Katznelson L, Finkelstein JS, Schoenfeld DA, Rosenthal DI, Anderson EJ, Klibanski A. Increase in bone density and lean body mass during testosterone administration in men with acquired hypogonadism. J Clin Endocrinol Metab. 1996 Dec;81(12):4358-65. doi: 10.1210/jcem.81.12.8954042. PubMed 8954042 ↗
Finkelstein JS, Klibanski A, Neer RM, Greenspan SL, Rosenthal DI, Crowley WF Jr. Osteoporosis in men with idiopathic hypogonadotropic hypogonadism. Ann Intern Med. 1987 Mar;106(3):354-61. doi: 10.7326/0003-4819-106-3-. PubMed 3544993 ↗
Jockenhovel F, Vogel E, Reinhardt W, Reinwein D. Effects of various modes of androgen substitution therapy on erythropoiesis. Eur J Med Res. 1997 Jul 28;2(7):293-8. PubMed 9233903 ↗
Behre HM, Bohmeyer J, Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in comparison to age-matched normal controls. Clin Endocrinol (Oxf). 1994 Mar;40(3):341-9. doi: 10.1111/j.1365-2265.1994.tb03929.x. PubMed 7514512 ↗
Davidson JM, Camargo CA, Smith ER. Effects of androgen on sexual behavior in hypogonadal men. J Clin Endocrinol Metab. 1979 Jun;48(6):955-8. doi: 10.1210/jcem-48-6-955. PubMed 447801 ↗
Snyder PJ, Peachey H, Berlin JA, Hannoush P, Haddad G, Dlewati A, Santanna J, Loh L, Lenrow DA, Holmes JH, Kapoor SC, Atkinson LE, Strom BL. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab. 2000 Aug;85(8):2670-7. doi: 10.1210/jcem.85.8.6731. PubMed 10946864 ↗
Baillargeon J, Urban RJ, Ottenbacher KJ, Pierson KS, Goodwin JS. Trends in androgen prescribing in the United States, 2001 to 2011. JAMA Intern Med. 2013 Aug 12;173(15):1465-6. doi: 10.1001/jamainternmed.2013.6895. No abstract available. Erratum In: JAMA Intern Med. 2013 Aug 12;173(15):1477. PubMed 23939517 ↗
Ullah MI, Riche DM, Koch CA. Transdermal testosterone replacement therapy in men. Drug Des Devel Ther. 2014 Jan 9;8:101-12. doi: 10.2147/DDDT.S43475. eCollection 2014. PubMed 24470750 ↗

Study documents

Protocol and statistical analysis plan · Feb 26, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04523480
Lead sponsor: University of Miami
Collaborators: Empower Research Inc
Responsible party: Ranjith Ramasamy, MD (Director of Male Fertility and Andrology, University of Miami, University of Miami) — Principal investigator
First posted: Aug 21, 2020
Start date: Mar 12, 2020
Primary completion: Dec 20, 2022
Completion: Dec 20, 2022
Results posted: Aug 14, 2023
Last update: Aug 14, 2023

Study contacts

Ranjith Ramasamy, MD

principal investigator · University of Miami

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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